Calidi Biotherapeutics Reports Q2 2025 Financial Results and Operational Highlights

Calidi Biotherapeutics reported Q2 2025 financial results and operational highlights. The company presented preclinical data at ASCO on CLD-401, demonstrating biological efficacy and reduced immune clearance. CLD-201 received FDA Fast Track Designation for soft tissue sarcoma treatment. Calidi raised $4.6 million through a warrant inducement offering, strengthening its balance sheet and extending its runway. The company expects IND filing for CLD-401 by the end of 2026.

Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotech company, reported its Q2 2025 financial results and operational highlights. The company presented promising preclinical data for CLD-401 at ASCO, demonstrating enhanced biological efficacy in delivering IL-15 superagonist to metastatic tumors. Additionally, CLD-201 received FDA Fast Track Designation for soft tissue sarcoma treatment.

Financially, Calidi raised $4.6 million through a warrant inducement offering, bringing total 2025 gross proceeds to $15.7 million. The company reported a net loss of $5.7 million ($1.99 per share) in Q2 2025, compared to $7.4 million in Q2 2024. Cash position stood at $5.3 million as of June 30, 2025.

Calidi secured FDA Fast Track for CLD-201, presented promising CLD-401 data, raised $4.6M, while reducing quarterly losses by 23% year-over-year. The company secured FDA Fast Track Designation for CLD-201, their stem cell-loaded oncolytic viral therapy for soft tissue sarcoma - a significant regulatory milestone that could accelerate approval timelines and validates their platform approach.

The preclinical data presented at ASCO for CLD-401 shows two critical advantages: the CD55 membrane expression that reduces immune clearance (solving a major challenge for systemic delivery of oncolytic viruses) and successful IL-15 superagonist delivery to metastatic sites. This suggests their RedTail platform may overcome the historical limitations of oncolytic virus therapies.

Financially, Calidi has shown improved capital efficiency with a 23% reduction in quarterly net loss ($5.7M vs $7.4M year-over-year) despite a modest increase in R&D expenses to $2.6M. The company reduced G&A costs by 14% to $3.1M, suggesting stronger operational discipline.

The $4.6M warrant inducement offering (bringing total 2025 funding to $15.7M) has extended their runway, though with $5.3M cash on hand (down from $9.6M at year-end 2024), their quarterly burn rate suggests they'll need additional financing within 2-3 quarters. The IND filing for CLD-401 expected by end of 2026 indicates a measured development timeline that aligns with their current resources.

References:
[1] https://www.stocktitan.net/news/CLDI/calidi-biotherapeutics-reports-second-quarter-2025-financial-results-xjtn9jnymus3.html
[2] https://oncodaily.com/oncolibrary/immune-oncology/cld-201-fastr-track